San Francisco Coordinating Center, California Pacific Medical Center Research Institute, San Francisco, California.
Department of Epidemiology and Biostatistics, University of California, San Francisco.
JAMA Intern Med. 2021 May 1;181(5):680-684. doi: 10.1001/jamainternmed.2020.9223.
Clinical trials conducted at clinical sites are limited to enrolling people who live nearby and are able to attend visits at clinics. Some types of clinical trials can be performed without clinical sites, which enables people to participate regardless of proximity to a clinical site or limitations that make visits difficult. Trials at clinical sites involve face-to-face relationships with in-person collection of informed consent, examinations, data, and specimens. In contrast, without clinical sites, informed consent and data are obtained online, limited examinations can be performed by telemedicine or visiting research nurses, biospecimens can be collected by visiting nurses or local laboratories, and treatments can be sent to homes or administered by nurses in participants' homes. Trials without clinical sites require internet access and must adapt to the lack of face-to-face interactions with study staff, with communication conducted by email, telephone, or video. Many trials cannot be performed entirely without clinical sites because they require examinations, tests, or treatments that must be given at a clinical site. However, some of the methods required for trials without sites, such as online data collection, follow-up visits by telemedicine or research nurses, and delivery of treatments to home, could reduce the need for visits to clinical sites and reduce the burden of participating in a clinical trial. When feasible, conducting clinical trials without clinical sites has the potential to expand participation and the generalizability of their results.
临床试验只能在附近居住并能够前往诊所就诊的人群中进行。有些类型的临床试验可以在没有临床站点的情况下进行，这使得人们无论距离临床站点的远近如何，或者由于限制而难以就诊，都能够参与临床试验。临床站点的试验涉及到与患者进行面对面的关系，包括亲自收集知情同意书、进行检查、收集数据和样本。相比之下，没有临床站点的情况下，知情同意书和数据是通过在线获得的，可以通过远程医疗或访问研究护士进行有限的检查，可以由访问护士或当地实验室收集生物样本，治疗可以送到家中或由护士在参与者家中进行。没有临床站点的试验需要互联网接入，并且必须适应缺乏与研究人员的面对面互动，通过电子邮件、电话或视频进行沟通。许多试验不能完全在没有临床站点的情况下进行，因为它们需要在临床站点进行检查、测试或治疗。然而，一些无站点试验所需的方法，如在线数据收集、远程医疗或研究护士的随访访问以及将治疗送到家中，可以减少对临床站点的访问需求，并减轻参与临床试验的负担。在可行的情况下，在没有临床站点的情况下进行临床试验有可能扩大参与度并提高其结果的普遍性。
